Effect of a Component of Fish Oil on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

NCT01200446 | Completed

• 1 other identifier: 1005001346
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Docosahexaenoic acid (DHA) is a component of fish oil that is known to support a healthy cardiovascular system, maintain brain function, reduce depression, and improve inflammatory diseases. The study hypothesis is that DHA supplementation will diminish exercise-induced bronchoconstriction and airway inflammation as compared to placebo.

Conditions

Asthma

Keywords

Asthma; Exercise-Induced Bronchoconstriction; Inflammation; Airway; Fish Oil; Docosahexaenoic Acid; DHA

Outcome Measures

Primary Outcomes (1)

• Pulmonary Function (Percent Change in FEV1, measured in Liters)

  The percent change in FEV1 is the percent change in the volume of air exhaled during the first second of a forced exhalation as measured before and after the surrogate exercise challenge.

  8 weeks

Secondary Outcomes (1)

• DHA Metabolite Concentration in Exhaled Breath Condensate

  8 weeks

Study Arms (2)

Placebo Docosahexaenoic Acid (DHA)

PLACEBO COMPARATOR

Eight subjects will take 8 placebo DHA capsules per day for 3 weeks.

Dietary Supplement: Placebo Docosahexaenoic Acid

Active Docosahexaenoic Acid (DHA)

EXPERIMENTAL

Eight subjects will take 8 active DHA capsules per day for 3 weeks.

Dietary Supplement: Docosahexaenoic Acid

Interventions

Docosahexaenoic Acid DIETARY_SUPPLEMENT

8 docosahexaenoic acid (4.0 grams) capsules per day for 3 weeks.

Also known as: DHA

Active Docosahexaenoic Acid (DHA)

Placebo Docosahexaenoic Acid DIETARY_SUPPLEMENT

8 placebo docosahexaenoic acid (corn and soy oil blend) capsules per day for 3 weeks.

Also known as: Corn Oil, Soy Oil

Placebo Docosahexaenoic Acid (DHA)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of asthma, based on medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma
• Diagnosis of EIB, based on a ≥10% fall in FEV1, a measure of lung function, after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge
• Not currently taking asthma maintenance medication or physician approval to discontinue current asthma medication for the duration of the study
• Not currently taking any fish oil supplements above the level recommended for adequate intake (if currently taking supplements, can participate if the subject stops taking the supplements for 2 weeks before starting the study and throughout the study)
• Agree to limit fish consumption to 1 fish meal per week throughout the study

You may not qualify if:

• Post-EVH FEV1 (the amount of air blown out in the first second of a forced exhalation) decreases by more than 50% compared to the subject's resting FEV1 at the first lab testing session
• Pregnancy
• History of cardiovascular disease, including hyperlipidemia (high cholesterol) and hypertension (high blood pressure)
• History of bleeding disorders or delayed clotting time
• History of diabetes
• History of seizures
• Allergy to fish oil
• Allergy to corn or soy products (placebo is a mixture of corn and soy oil)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

Location

Related Publications (2)

• Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.

  PMID: 12904324 BACKGROUND

• Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49. doi: 10.1378/chest.129.1.39.

  PMID: 16424411 BACKGROUND

MeSH Terms

Conditions

Asthma; Inflammation

Interventions

Docosahexaenoic Acids; Corn Oil; Soybean Oil

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Timothy D Mickleborough, PhD

  Indiana University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 13, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 26, 2011

Record last verified: 2011-05

Locations

US (1)